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NCT02544893 Clinical Trial

Postoperative Analgesic Effects of Using Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block

Pain Clinical Trial

Official title:
Postoperative Analgesic Effects of Using Bupivacaine Alone or Added Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block in Thoracotomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02544893
Other study ID # 2014/649
Secondary ID
Status Completed
Phase Phase 4
First received September 7, 2015
Last updated August 2, 2016
Start date September 2015
Est. completion date March 2016

Study information
Verified date August 2016
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy

Description:

paravertebral block is commonly used in the treatment for acute and chronic pain.The duration of paravertebral block could theoretically be prolonged with neurolytic agents. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- ASA 1-2

- 18-65 aged

- patient undergoing thoracotomy

Exclusion Criteria:

- chronic opioid consumption

- bupivacaine and dexmedetomidine allergies

- coagulopathy

- infection at the needle insertion side

- chronic liver and kidney disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• bupivacaine
21 ml 0.5 %bupivacaine is applied paravertebral space
• dexmedetomidin
1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied paravertebral space
• serum physiologic
21 ml serum physiologic is applied paravertebral space

Locations
Country Name City State
Turkey Erciyes University Medicine Faculty Kayseri

Sponsors (1)
Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary opioid consumption patient controlled analgesia postoperative 24 hours No
Secondary visual analog scale visual analog scale postoperative 1 day No
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